PRETORIA – The Treatment Action Campaign (TAC) and Doctors Without Borders (MSF) today delivered a memorandum to the Department of Trade and Industry (dti) at the National Workshop on Intellectual Property and Public Health in Pretoria, outlining needed reforms to South Africa’s patent laws in order to expand access to more affordable drugs.

The country’s current patent laws can delay the introduction of generic medicines in South Africa, limiting access for patients to more affordable treatment. Unless specific changes are incorporated into an anticipated draft intellectual property (IP) policy from the dti, South Africans will continue to pay unbearably high prices for medicines, even when lower-cost generic alternatives are available elsewhere.

“The dti has consistently missed deadlines to release the draft IP policy for public comment,” said Julia Hill, MSF’s Access Advocacy Officer in South Africa. “We are seriously concerned that the dti is backtracking on its promises for patent law reform, and again make the urgent call for change in our memorandum.”

TAC and MSF are asking for the IP policy to include the implementation of a substantive pre-grant patent examination system, as required by Section 34 of the existing Patents Act, as well as stricter patentability criteria. These changes, along with other patent law reforms, will promote generic competition and increase access to more affordable medicines.

TAC and MSF note that companies keep prices artificially high in South Africa by filing for multiple patents on the same medicine. This practice, known as ‘evergreening’, extends patent monopolies and blocks generic competition. For example, in South Africa, to treat a patient with chronic myeloid leukaemia (CML) for one year with Novartis’ cancer drug imatinib, costs over R387,000 – pricing it out of reach for most South Africans and medical aid schemes. Even though Novartis’ 20-year patent on the imatinib compound expired in South Africa in April 2013, an additional patent for a ‘new use’ of imatinib does not expire until 2022.

This additional patent delayed generic manufacturer Cipla from introducing generic imatinib onto the South African market, because Cipla’s product also indicates it can be used to treat a condition prescribed by Novartis’ extended patent. The two companies eventually settled the matter out of court under confidential terms. The Cipla product is now available in South Africa at a 46% price reduction compared to Novartis’ imatinib. Yet, Novartis’ patent remains enforceable in South Africa which means other generic producers could face similar constraints to introducing more affordable versions of imatinib.

In countries with truly competitive markets, even further price reductions on imatinib have been realised. India, for example, has not patented imatinib, and 11 manufacturers produce the drug, offering some of the lowest prices in the world. The table below illustrates the vast price disparities between South Africa and India to treat one CML patient for a year with imatinib. (Prices per patient per year (ppy) are calculated based on a daily dosage of 400mg imatinib, over 365 days.)

MANUFACTURER

SOUTH AFRICA

INDIA

PRICE DIFFERENTIALS

Novartis

R 387,834

R 237,549

39% less in India

Cipla

R 208,780

R 17,816

91% less in India

Glenmark

N/A

R 10,694

Cheapest SA option almost 20x more expensive

Unlike South Africa, countries like India and Brazil have avoided granting secondary patents by implementing patent examination systems, and by upholding legislation that requires a high standard of innovation in order for a medicine to be granted a patent. Under Indian and Brazilian patent regimes, discovering a new use of a medicine like imatinib is not considered sufficient innovation to warrant an additional period of market exclusivity.

“As long as companies like Novartis are granted secondary patents on medicines in South Africa, generic companies risk time-consuming litigation processes that keep affordable versions of drugs away from patients,” said Hill. “To realise lower drug prices for South Africans, the dti must prioritise patent law reforms that would curb evergreening and abusive patenting of medicines.”

The memorandum TAC and MSF delivered at the National Workshop on Intellectual Property and Public Health in Pretoria made the following demands on behalf of ordinary South Africans:

1) Implement a substantive patent examination system for pharmaceutical patents to limit the number of patents granted in South Africa. Excessive patenting keeps prices artificially high and medicines unaffordable for patients. Section 34 of the South African Patents Act requires that all patent applications are substantively examined, but to date, the dti has failed to take necessary steps to implement this provision.

2) Curtail evergreening and abusive patenting through stricter patentability criteria. The Patents Act does not explicitly exclude patentability of new forms, new uses and new formulations of already-existing medicines. South Africa should amend patentability criteria to interpret flexibilities available under international law in a pro-public health manner, and prevent the patenting of trivial changes to existing medicines.

3) Enhance public transparency of the Patents Office. In South Africa, patent applications are not available for public scrutiny, and the claims of granted patents are only accessible through time-consuming case-by-case requests to the Patents Office. The lack of information available online or through easily accessible publications makes it difficult to know when patents have been applied for, and to oppose abusive patents.

4) Allow for pre-grant and post-grant patent opposition by a broad range of third parties. Greater transparency from the Patents Office should be accompanied by changes to the law that allow patent applications and granted patents to be opposed by a broad range of third parties, including generic manufacturers, researchers, civil society, and other interested persons. Patent opposition provides patent offices with additional input from various stakeholders regarding the public health impact a patent may have, and helps curb abusive patenting of pharmaceuticals.

5) Broaden the grounds and facilitate procedures for issuing a compulsory license. South Africa can issue compulsory licenses for the production of generic versions of medicines that are rendered inaccessible due to high cost or limited supply—but South Africa has never issued a compulsory license for a pharmaceutical. It would cost an estimated R1million in legal fees and takes up to three years of court proceedings to obtain a compulsory license at present—amended and easier procedures are needed.

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About the Campaign

Fix the Patent Laws is a campaign of the Treatment Action Campaign (TAC). TAC is a non-profit organisation that seeks to ensure that every person living with HIV has access to quality, comprehensive prevention and treatment services to live a healthy life. Through this blog we will highlight how amending South Africa’s Patents Act 57 of 1978 will reduce the cost of medicines, improving the health and saving the lives of millions of South Africans.

Read the TAC and MSF campaign pamphlet

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Unless explicitly stated the views expressed here are those of the authors and do not necessarily reflect the official position of the Treatment Action Campaign